The Political Economy of Market Power in Pharmaceuticals.

The pharmaceutical industry is among the most politically powerful business sectors in the United States today. This article describes how this industry has successfully entrenched its power, with attention to four sources of power: property power, vertical power over politics, ideational power, and material power. Attempts to reform the industry must grapple with these forms of power, which are not easily separated and which, in the current environment, tend to reinforce one another.

The Constitutionality of Medicare Drug-Price Negotiation under the Takings Clause.

In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a "taking" of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and services, including patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US's most important state and federal health care programs.

Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Addressing the Risks That Trade Secret Protections Pose for Health and Rights.

Human rights frameworks afford everyone the right to health and the right to enjoy the benefits of scientific progress and its applications. Both come together to create state obligations to ensure access to medicines and other health technologies. Though the impact of patents on access to high-quality, affordable medicines and health technologies has been well described, there has been little attention to the impact of trade secrecy law in this context. In this paper, we describe how trade secrecy protection comes into conflict with access to medicines-for example, by preventing researchers from accessing clinical trial data, undermining the scale-up of manufacturing in pandemics, and deterring whistleblowers from reporting industry misconduct. The paper proposes measures to diminish the conflict between trade secrecy and health that are consistent with international law and will advance health without undermining innovation.

Realizing Public Rights Through Government Patent Use.

A substantial portion of biomedical R&D is publicly funded. But resulting medicines are typically covered by patents held by private firms, and priced without regard to the public's investment. The Bayh-Dole Act provides a possible remedy, but its scope is limited.

Confidentiality Orders and Public Interest in Drug and Medical Device Litigation.

Litigation involving drug and medical device manufacturers has the potential to reveal important information about product efficacy and safety as well as company marketing. Prevailing legal standards recognize the public's interest in having access to certain types of information in lawsuits. However, in practice, courts and litigants commonly use overly broad or unwarranted confidentiality orders, which can prevent the public from accessing important public health information that emerges during litigation. This Special Communication reviews the rules governing confidentiality orders and discusses the tension between these rules and prevailing legal practices relating to court secrecy in medical product litigation, including competing interests among manufacturers, plaintiffs, and courts. Using examples of successful efforts to challenge confidentiality orders, we describe how these prevailing legal practices can undermine access to information by patients, clinicians, and the US Food and Drug Administration and also obscure patterns of injury and disease associated with the drugs and medical devices at issue. We then discuss several ways to advance access to information important to public health that emerges during litigation, focusing particularly on the role of medical experts engaged in cases.

Order Without Intellectual Property Law: Open Science in Influenza.

Today, intellectual property (IP) scholars accept that IP as an approach to information production has serious limits. But what lies beyond IP? A new literature on "intellectual production without IP" (or "IP without IP") has emerged to explore this question, but its examples and explanations have yet to convince skeptics. This Article reorients this new literature via a study of a hard case: a global influenza virus-sharing network that has for decades produced critically important information goods, at significant expense, and in a loose-knit group--all without recourse to IP. I analyze the Network as an example of "open science," a mode of information production that differs strikingly from conventional IP, and yet that successfully produces important scientific goods in response to social need. The theory and example developed here refute the most powerful criticisms of the emerging "IP without IP" literature, and provide a stronger foundation for this important new field. Even where capital costs are high, creation without IP can be reasonably effective in social terms, if it can link sources of funding to reputational and evaluative feedback loops like those that characterize open science. It can also be sustained over time, even by loose-knit groups and where the stakes are high, because organizations and other forms of law can help to stabilize cooperation. I also show that contract law is well suited to modes of information production that rely upon a "supply side" rather than "demand side" model. In its most important instances, "order without IP" is not order without governance, nor order without law. Recognizing this can help us better ground this new field, and better study and support forms of knowledge production that deserve our attention, and that sometimes sustain our very lives.

'Government Patent Use': A Legal Approach To Reducing Drug Spending.

The high cost of patent-protected brand-name drugs can strain budgets and curb the widespread use of new medicines. An example is the case of direct-acting antiviral drugs for the treatment of hepatitis C. While prices for these drugs have come down in recent months, they still create barriers to treatment. Additionally, prescribing restrictions imposed by insurers put patients at increased risk of medical complications and contribute to transmission of the hepatitis C virus. We propose that the federal government invoke its power under an existing "government patent use" law to reduce excessive prices for important patent-protected medicines. Using this law would permit the government to procure generic versions of patented drugs and in exchange pay the patent-holding companies reasonable royalties to compensate them for research and development. This would allow patients in federal programs, and perhaps beyond, to be treated with inexpensive generic medicines according to clinical need-meaning that many more patients could be reached for no more, and perhaps far less, money than is currently spent. Another benefit would be a reduction in the opportunity for companies to extract monopoly profits that far exceed their risk-adjusted costs of research and development.

Polymorphs and prodrugs and salts (oh my!): an empirical analysis of "secondary" pharmaceutical patents.

BACKGROUND: While there has been much discussion by policymakers and stakeholders about the effects of "secondary patents" on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents. METHODOLOGY/PRINCIPAL FINDINGS: We read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims ("independent" secondary patents). We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs. CONCLUSIONS/SIGNIFICANCE: Policies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active "life cycle management" or "evergreening" of patent portfolios in the industry.

Commentary: innovation policy for a new era.

This commentary offers a response to the Sonderholm, Bird, and Flynn et al. articles, and argues that the current innovation crisis requires more ambitious approaches, as well as a serious consideration of alternative mechanisms for R&D such as prizes.